It is not known if PREZCOBIX® is safe and effective in children under 18 years of age.

When used with other antiretroviral medicines to treat HIV-1 infection, PREZCOBIX® may help:

reduce the amount of HIV-1 in your blood. This is called “viral load.”

increase the number of CD4+ (T) cells in your blood that help fight off other infections.

PREZCOBIX® is always taken in combination with other HIV medications for the treatment of HIV-1 infection in adults. PREZCOBIX® should be taken once daily with food.

PREZCOBIX® does not cure HIV-1 infection or AIDS, and you may still experience illnesses associated with HIV-1 infection. You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses.

Ask your healthcare provider if you have any questions on how to prevent passing HIV to other people.

Please read the Important Safety Information below and talk to your healthcare provider to learn if PREZCOBIX® is right for you.

Important Safety Information

What is the most important information I should know about PREZCOBIX®?

PREZCOBIX® may cause liver problems. Some people taking PREZCOBIX® may develop liver problems which may be life-threatening. Your healthcare provider should do blood tests before and during your treatment with PREZCOBIX®.

Signs and symptoms of liver problems include dark (tea-colored) urine, yellowing of your skin or whites of your eyes, pale-colored stools (bowel movements), nausea, vomiting, pain or tenderness on your right side below your ribs, or loss of appetite. Tell your healthcare provider if you develop any of these symptoms.

PREZCOBIX® may cause severe or life-threatening skin reactions or rash. Sometimes these skin reactions and skin rashes can become severe and require treatment in a hospital. Call your healthcare provider right away if you develop a rash.

Stop taking PREZCOBIX® and call your healthcare provider right away if you develop any skin changes with symptoms such as fever, tiredness, muscle or joint pain, blisters or skin lesions, mouth sores or ulcers, red or inflamed eyes like “pink eye” (conjunctivitis).

PREZCOBIX®, when taken with certain other medicines, can cause new or worse kidney problems, including kidney failure. Your healthcare provider should check your kidneys before you start and while you are taking PREZCOBIX®.

Serious problems can happen if you take any of these medicines with PREZCOBIX®.

What should I tell my healthcare provider before taking PREZCOBIX®?

About all health problems. Tell your healthcare provider if you have liver problems, including hepatitis B or hepatitis C, have kidney problems, are allergic to sulfa (sulfonamide), have diabetes, have hemophilia, or have any other medical condition, are pregnant, breastfeeding, or plan to become pregnant or breastfeed. Tell your healthcare provider if you become pregnant while taking PREZCOBIX®.

About all medicines you take. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with PREZCOBIX®. Keep a list of your medicines to show your healthcare provider and pharmacist. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take PREZCOBIX® with other medicines.

What are the possible side effects of PREZCOBIX®?

The most common side effects of darunavir, one of the medicines in PREZCOBIX®, include diarrhea, nausea, rash, headache, stomach area (abdominal) pain, and vomiting.

Other possible side effects include:

High blood sugar, diabetes or worsening diabetes, and increased bleeding in people with hemophilia have been reported in patients taking protease inhibitor medicines, including PREZCOBIX®.

Changes in body fat can happen in people who take HIV-1 medicines. The exact cause and long-term health effects of these changes are not known.

Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time.

These are not all of the possible side effects of PREZCOBIX®. For more information, ask your healthcare provider.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736).

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This information is intended for the use of our customers, patients, and healthcare providers in the United States and Puerto Rico only. Laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here may not be appropriate for use outside the United States and Puerto Rico.

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